Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma

NCT ID: NCT01441661

Last Updated: 2013-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-06-30

Brief Summary

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This non-interventional study includes patients with advanced renal cell carcinoma who are treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine use of Sunitinib.

Detailed Description

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Because State Food and Drug Administration (SFDA) exempted manufacturers from conducting clinical trials of Sunitinib in China, overall efficacy and safety data of Sunitinib in Chinese patients with renal cell carcinoma were deficiency. The investigators carried out this research project will be sufficient evidence, and help clinicians in China to make decision in real daily practice.

Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sunitinib Renal Cell Carcinoma

Patients diagnosed with Renal Cell Carcinoma (RCC) and treated with Sunitinib from 2008 to present will be eligible. This will include current active patients as well as patients who have expired and have medical records available.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed, unresectable advanced renal cell carcinoma;
* Sunitinib as first-line treatment alone or combined with other therapies.

Exclusion Criteria

* History of Grade 3/4 severe allergic reaction to Sunitinib or its metabolites
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Cancer Foundation, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhangqun Ye, MD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Tongji Hospital, Tongji Medical College of Hust

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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CFC20110815

Identifier Type: -

Identifier Source: org_study_id

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